Another stem cell lawsuit: Stemedica sued by board member over alleged mishandling of funds

Stem cell clinic biotech Stemedica has just been sued by one of its own board members based on allegations related to money the company raised, according to CourtHouseNews. The actual suit, filed by an investment company Tiara Holdings and board member Anthony Marlon, can be read here.

CourtHouseNews writes:

“Tiara Holdings II LLC sued Stemedica Cell Technologies Inc. and its top three officers on April 6 in Clark County Court. The officers are CEO and Chairman of the Board Roger Howe, Vice Chairman and CEO Maynard Howe and President and Chief Medical Officer Nikolai Yankovich.”…Dr. Anthony M. Marlon, a medical doctor and businessman, holds 430,000 shares of Stemedica through Tiara Holdings, where he is a member. He also is a member of the board of Stemedica, he says in the complaint.”

stemedica

Note that “Yankovich” seems to be a typo as the Stemedica leader in question is Nikolai Tankovich.

The allegations in the suit are summarized by CourtHouseNews this way:

“Stemedica’s founders have operated a nearly 10-year investment scheme, wherein they have raised over $110 million dollars from various individual investors for the purported purpose of funding and establishing a stem cell company,” Tiara says in the lawsuit.

Tiara claims the Howes and Tankovich “have used these investor funds, in whole or in part, to benefit themselves and their associates through excessive compensation and lavish personal expenses and related party transactions.”

“Stemedica’s founds have concealed and perpetuated this fraud through purported operating subsidiaries, which permitted them to divert millions to benefit them without raising questions or concerns from Stemedica’s investors and shareholders,” Tiara says.”

and

“It also seeks damages and punitive damages for fraud, breach of fiduciary duty, unjust enrichment and bad faith.”

Maynard Howe reportedly told CourtHouseNews that the allegations are false.

Dr. Anthony M. Marlon Stemedica

The Stemedica website still lists Dr. Marlon as a board member (see screenshot above).

Stemedica has seen some other past controversy as in part noted in the new suit related to a KPBS investigation of the San Diego company and ties reported in that piece to the stem cell transplants received by patient Jim Gass, who later developed a spinal tumor. The origin of Gass’s tumor remains unknown to my knowledge and may have had nothing to do with Stemedica’s cells, but the stem cell community would benefit from more clarity on that situation. Stemedica also garnered major media attention further back for its role in a non-FDA-approved stroke treatment received outside the U.S. by hockey legend Gordie Howe (no relation to the company’s Howe brothers).

Another San Diego stem cell businesses, Stemgenex, is also the subject of a lawsuit, in its case related to allegations of improper marketing claims. Additional recent stem cell clinic-related lawsuits have been filed, settled, or remain active as I discuss here and here.

Big HT to Alexey Bersenev.

Vote now for your pick for Stem Cell Person of the Year 2016

Vote on your pick for the top stem cell outside the box thinker and positive impactor in 2016 from the 20 choices below. The top 10 vote getters will be finalists from which I will have the tough task of picking the one winner as Stem Cell Person of the Year along with the $2,000 prize and recognition.

You can vote once per day. The voting closes in 10 days on December 15th at 11:59pm Pacific Time. Read more about the 20 nominees here.

20 Nominees for Stem Cell Person of the Year 2016 Award

stem-cell-person-of-the-year-awardI received a score of great nominations for the Stem Cell Person of the Year 2016 Award and have briefly described the twenty nominees below. The point of the award is to honor the top positive stem cell leader who specifically thinks outside the box and takes risks.

I’ve started an on-line vote where you can vote once per day for your favorite nominee(s) for Stem Cell Person of the Year. The top half or so of nominees getting the most votes will be the finalists from which I will choose the final winner, who receives the $2,000 prize and international recognition as a global leader in the stem cell and regenerative medicine field.

Past winners of the Stem Cell Person of the Year Award include the following:

  • Top stem cell scientist Jeanne Loring in 2015.
  • Pioneering vision and pluripotent stem cell clinical researcher, Masayo Takahashi in 2014.
  • Neural stem cell scientist and very effective Italian politician Elena Cattaneo in 2013.
  • Stem cell patient advocate Roman Reed in 2012.

Here are the 2016 nominees in alphabetical order by first name with some description of who they are and a bit of the words from the person(s) who nominated them in some cases. Where I could find a link to websites describing their accomplishments, I have provided those.

Amy Wagers, Professor at Harvard. She has a long track record of cutting edge research on stem cells including recently very provocative work on the role of stem cells in human aging and approaches to reversing aging.

Arnold Caplan, Professor at Case Western Reserve. He is often considered the “father” of the mesenchymal stem/stromal cell (medicinal signaling cell) field and has done important research on MSCs over many years.

Connie Eaves, Distinguished Investigator at Terry Fox Laboratory at UBC. She has a remarkable track record of innovative research on stem cells including both normal and cancer stem cells and a reputation as a fantastic mentor and leader in the field more generally. “Brilliant scientist with unmatched piercing view of science”.

Hiroshi Nagashima, Professor at Meiji University, Tokyo. “A true translational scientist (with a wicked sense of humor!)” He works in part on cloning technology and could revolutionize organ transplantation approaches leading to huge impact.

Jim Gass. Jim is a patient who suffered a stroke and then sought stem cell treatments to try to reverse some of the damage. Somewhere along the lines, one or more of the unproven stem cell therapies he received caused him to develop a spinal tumor. He had the courage to go public with his story and describe his experiences, potentially risking litigation. “A gutsy man who has prevented others from getting injured.”

John Pimanda, Associate Professor of Medicine and Stem Cell Biology, UNSW Australia. He researches transcriptional regulation of adult stem cells and now the use of fat stem cells for spine injury.

Judy Roberson. She is a tireless Huntington’s Disease (HD) advocate, always working to make a positive difference. “She is a straight shooter who will tell you what she thinks and work to make it a reality.”

Jun Takahashi. He is a Professor at CiRA and pluripotent stem cell biology researcher. Jun has done pioneering IPSC research and is working to start a very exciting Parkinson’s Disease clinical trial using IPSC in Japan.

Margaret Goodell, Professor at Baylor College of Medicine. She is an internationally respected scholar in the stem cell field. She conducts cool, innovative research on transcriptional and epigenetic regulation of hematopoietic stem cells and how this goes awry in leukemias.

Mike West. Often mentioned as one of the founders of the regenerative medicine field, he is the leader of BioTime and is a thought leader in the field. “Mike knows all about taking risks in regenerative medicine leading to big, positive leaps forward.”

Nissim Benvenisty, Professor of Genetics at the Hebrew University of Jerusalem. He is a super-prolific, long-time stem cell researcher. His latest work this year was on revolutionary production of haploid ES cells.

Oliver Brustle, Professor and Director of the Institute of Reconstructive Neurobiology and Professor of Reconstructive Neurobiology at the University of Bonn Medical Center. He conducts innovative neural stem cell research and is a globally respected stem cell leader.

Randy Mills, President and CEO of CIRM. He has been a leader in stem cell biotech for years and has shaken things up at the helm of CIRM with a much more translational emphasis. “Randy has CIRM on track to meaningful clinical outcomes in a way that I cannot imagine another leader could have achieved. The outcome will change the world.”

Richard Ambinder, Johns Hopkins Hospital. Professor Ambinder has done pioneering work in the area of stem cells and viruses, including HIV, as well as stem cells for patients with hematopoietic malignancies. A scientist with a prodigious publication record of high-impact papers.

Robert Lanza. He has been a regenerative medicine leader for, what, decades? Long time scientific leader behind ACT and then its new incarnation as Ocata, which was purchased by Astellas and he leads global regenerative medicine at Astellas.”We expect something new and big from Bob at every turn”.

Sally Temple, Scientific Director, Co-Founder, and Principle Investigator at the Neural Stem Cell Institute. She is also the President of ISSCR. Scholar and innovative researcher in the stem cell field with a focus on stem cells in the brain. Past MacArthur Fellow. “One of the brightest developmental biologists in the world and a natural leader.”

Sheng Ding, Senior Investigator, Gladstone Institute of Cardiovascular Disease. Dr. Ding has done some of the most creative and impactful research in the stem cell field to date, and continues to crank out new discoveries in particular related to chemical reprogramming. He also has co-founded a number of exciting biotechs including Fate Therapeutics. “He has been a positive leader in the stem cell field, and his outside-of-the-box thinking has greatly enhanced our collective efforts to advance the field.”

Shoukhrat Mitalipov, Professor at ONPRC and OHSU. Shoukhrat is a top researcher in the stem and germ cell arenas of research including cloning and mitochondrial transfer, with cutting edge high impact papers published every year. “Fearless and one of the premier innovators in the field”.

Ted Harada (posthumous). Ted was one of the most prominent patients participating in a stem cell clinical trial ever. He fought for patients and efforts such as right to try every step along the way, and brought people together in the field. You can see his obituary and tributes here.

Theresa Liao. Powerful advocate for the use of stem cells to treat recessive dystrophic epidermolysis bullosa (RDEB). Through relentless advocacy she has made a profound difference in this area of clinical research.  “A parent and visionary patient advocate.”

Where does stem cell business Stemedica go from here after KPBS investigative report?

stemedicaFor quite a while there San Diego-based stem cell business Stemedica had a good run of publicity with reports of high-profile professional sports legends getting stem cells and the media reporting apparent good outcomes for stroke recovery, but more recent times have yielded some different publicity. An investigative report by KPBS reporter David Wagner raised some issues regarding the company. Here my take on Wagner’s report.

In his two-part piece (here and here), Wagner in part chronicled the story of stroke patient Jim Gass who ended up with a tumor on his spine after receiving several different stem cell interventions around the world over a period of years including one recently down in Tijuana administered by Dr. Cesar Amescua, who is not an employee of Stemedica.

According to Wagner’s report that last treatment involved two kinds of stem cells, one of which (adult stem cells) was reportedly manufactured by Stemedica. The other cells, fetal neural stem cells, were produced by Global Stem Cell Health. A Stemedica director was reportedly the one who referred Gass to the doctor down in Tijuana.

Many questions remain unanswered.

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KPBS piece sheds new light on Jim Gass stem cell case, ties to San Diego firms

KPBS reporter David Wagner has an important new piece out today on for-profit investigational stem cell treatments and he focuses to a large extent on a stem cell business in San Diego called Stemedica. If you’ve heard of this company it might be in part because they were involved in the Gordie Howe stem cells for stroke story that got so much buzz.

At a personal level the KPBS story is about the experience of patient Jim Gass, who received a number of non-FDA approved stem cell treatments outside the U.S. and ultimately ended up with a tumor on his spine. 

To be clear, Gass was not directly treated by Stemedica, but Wagner’s article makes the case that there are two relevant links with the stem cell business: a referral of Gass by a Stemedica director to a doctor in Mexico who did a treatment and the use of an MSC product made by Stemedica in that treatment.

Gass was brave enough to go public with his overall stem cell story a few months back. As part of her New York Times piece on Gass earlier this summer, Gina Kolata just briefly mentioned a possible indirect tie to Stemedica:

“I began doing research on the internet,” Mr. Gass said. He was particularly struck by the tale of the former football star and professional golfer John Brodie who had a stroke, received stem cell therapy in Russia and returned to playing golf again.

So Mr. Gass contacted a company, Stemedica, that had been involved with the clinic, and learned about a program in Kazakhstan. When Mr. Gass balked at going there, the Russian clinic referred him to a clinic in Mexico. That was the start of his odyssey.”

In the new piece on Jim Gass’ experience, Wagner provides additional concrete material on this situation in the form of emails to/from Gass, new information in the written part of the article, and via a startling video interview with Stemedica spokesman Dave McGuigan (below).

Wagner writes about how Gass’ treatment took shape:

“Gass traveled to Hospital Angeles in Tijuana, Mexico with the hope of recovering from a debilitating stroke. He received stem cells from Dr. Cesar Amescua based on a referral from Stemedica Cell Technologies, Inc., a San Diego company known for reportedly helping famous former athletes like hockey legend Gordie Howe make “miraculous” recoveries from strokes.”

What is the evidence for that referral that is mentioned?

The email documentation included with the article indicates that Marcie Frank of Stemedica referred Gass to Amescua (see image of part of the email below) in the form of saying, “Please contact Dr. Cesar Amescua”.

jim-gass-stemedica-email

Screenshot of part of Jim Gass email with Stemedica’s Marcie Frank

There are also Jim Gass’ own recollections of his experiences and his photo/video of being injected.

What happened next?

Gass went forward with the treatment, writes Wagner, which involved two kinds of stem cells:

cesar-anescua-jim-gass

Image from KPBS and Jim Gass

“Gass said he followed Stemedica’s referral and got in touch with Dr. Amescua. He said further down the line, he was told that for $30,000, he could receive a round of treatment involving two different types of stem cells.

The first type, Gass said he was told, would be mesenchymal stem cells. He said he was informed that they would be manufactured by Stemedica, and would be injected into a vein in his arm. Stemedica said its mesenchymal stem cells are derived from adult bone marrow.

Gass said he was told that the other type of stem cell would be fetal in origin, and would be injected directly into his cerebrospinal fluid. These fetal neural stem cells, Gass recalled being told, would be procured from Russia not by Stemedica, but by a different company, Global Stem Cell Health (GSCH).”

It’s not at all clear how Gass developed a spinal tumor nor for sure which of the several stem cell treatments he got around the world over the years might have contributed to the tumor.

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